MedisourceRx
Form 483 issued September 27, 2018 · Los Alamitos, California
- Inspection
- Sep 12 – Sep 27, 2018
- Investigators
- Bryan A. Galvez· Stephanie A. Slater
- Observations
- 7
- Pages
- 10
- FEI number
- 3013316698
In short: On September 27, 2018, FDA issued a Form 483 with 7 observations to MedisourceRx in Los Alamitos, California (FEI 3013316698) after an inspection that ran Sep 12 – Sep 27, 2018. The investigators were Bryan A. Galvez and Stephanie A. Slater. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
EMPl.OYEE(S) SIGNATURE Employees engaged in the manufacture, processing, packing and holding of a drug product lack…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmMedisourceRx history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MedisourceRx?
FDA listed 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected MedisourceRx?
Bryan A. Galvez and Stephanie A. Slater are named on this Form 483, for the inspection of Sep 12 – Sep 27, 2018. Each investigator has a profile showing what they cite most.
When was MedisourceRx inspected by FDA?
The inspection ran Sep 12 – Sep 27, 2018, and the Form 483 is dated September 27, 2018.
How do I get the full Form 483 for MedisourceRx?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.